There is an enormous need to make clinical assays faster, cheaper and simpler to perform. One way towards this goal is to simplify the analytical instruments and the testing process so that complex tests can be performed by non-technical employees or even the patients themselves. Another way is to speed-up the diagnostic process by immediately processing the test data and providing the results to authorized individuals who need the information.
Substantial effort has been devoted to miniaturization and integration of various assay operations. Among the newly developed devices are bio-chips and bio-discs. As described in U.S. Pat. No. 6,048,699 to Foley et al., bio-chips are built using silicon chip photolithography techniques, with each chip containing arrays of test sites formed on a substrate. Each of the test sites includes probes therein to bind with target molecules from samples applied to the device, e.g., deposited onto the probes. The binding of a molecule to a probe is noted, thereby identifying the molecule of interest.
Bio-discs are specially designed optical discs that contain all the necessary elements to perform diagnostic assays. Rotation of the bio-disc in a disc drive, such as a CD-ROM/DVD drive, provides a centrifuge capability to prepare and manipulate test samples, and the laser reader in the drive serves as the analytical tool to read the test results. The bio-disc has been described in detail in U.S. Pat. Nos. 5,892,577 and 6,256,088 to Gordon, and U.S. Pat. No. 6,030,581 to Virtanen, which are incorporated herein by reference.
To improve productivity and quality of test data processing, a number of computer-based systems have been developed to analyze and relay medical information. U.S. Pat. No. 5,631,844 to Margrey et al. generally describes a system for simultaneously analyzing medical specimens at remote locations and accessing, for evaluation, the results of each of the analyses at a central laboratory. The system includes a server for storing data in databases and a central laboratory interacting with dedicated computers at each remote locations through the server to analyze the various tests performed on the medical specimens. Interface software is used so that the dedicated computers can interact with the analytical instruments. The system may be used to review, accept or reject test results.
U.S. Pat. No. 6,018,713 to Coli et al. generally describes a network-based system for ordering and reporting medical tests. In this system, computers at the hospitals, laboratories, physicians' and insurers' offices are all inter-connected by a network, such as the Internet. A health care professional may order various tests and retrieve the results of the ordered tests using the system.
U.S. Pat. No. 5,793,969 to Kamentsky et al. describes a network system for reviewing and analyzing computer-encoded microscope slides. Specimens on microscope slides may be scanned using a laser or a video camera. The scanning device is interfaced with an encoding device to record information about the specimen. The digitalized information may be then stored on a network server for analysis.
However, despite these recent advances, there remains a need for a complete assay configuration that combines the simplified assay devices with a data analysis and distribution system so that the diagnostic assays can be performed efficiently and accurately with low cost and rapid turnaround time.